TY - JOUR
T1 - Comparative effectiveness of cladribine tablets versus other oral disease-modifying treatments for multiple sclerosis
T2 - Results from MSBase registry
AU - Spelman, Tim
AU - Ozakbas, Serkan
AU - Alroughani, Raed
AU - Terzi, Murat
AU - Hodgkinson, Suzanne
AU - Laureys, Guy
AU - Kalincik, Tomas
AU - Van Der Walt, Anneke
AU - Yamout, Bassem
AU - Lechner-Scott, Jeannette
AU - Soysal, Aysun
AU - Kuhle, Jens
AU - Sanchez-Menoyo, Jose Luis
AU - Blanco Morgado, Yolanda
AU - Spitaleri, Daniele LA
AU - van Pesch, Vincent
AU - Horakova, Dana
AU - Ampapa, Radek
AU - Patti, Francesco
AU - Macdonell, Richard
AU - Al-Asmi, Abdullah
AU - Gerlach, Oliver
AU - Oh, Jiwon
AU - Altintas, Ayse
AU - Tundia, Namita
AU - Wong, Schiffon L
AU - Butzkueven, Helmut
N1 - Funding Information:
The authors wish to thank Jason Allaire, PhD, of Generativity Solutions Group for his assistance with editing the paper; this assistance was funded by EMD Serono Research & Development Institute, Inc., Billerica, MA, USA (an affiliate of Merck KGaA). Naomi Killen of inScience Communications, Springer Healthcare Ltd., UK, performed the manuscript submission; support for the manuscript submission was funded by Merck Healthcare KGaA, Darmstadt, Germany. The authors agree to the manuscript submission via a third party, and all declarations and conflicts of interest have been previously approved.
Publisher Copyright:
© The Author(s), 2022.
PY - 2022/11/26
Y1 - 2022/11/26
N2 - BACKGROUND: Effectiveness of cladribine tablets, an oral disease-modifying treatment (DMT) for multiple sclerosis (MS), was established in clinical trials and confirmed with real-world experience.OBJECTIVES: Use real-world data to compare treatment patterns and clinical outcomes in people with MS (pwMS) treated with cladribine tablets versus other oral DMTs.METHODS: Retrospective treatment comparisons were based on data from the international MSBase registry. Eligible pwMS started treatment with cladribine, fingolimod, dimethyl fumarate, or teriflunomide tablets from 2018 to mid-2021 and were censored at treatment discontinuation/switch, death, loss to follow-up, pregnancy, or study period end. Treatment persistence was evaluated as time to discontinuation/switch; relapse outcomes included time to first relapse and annualized relapse rate (ARR).RESULTS: Cohorts included 633 pwMS receiving cladribine tablets, 1195 receiving fingolimod, 912 receiving dimethyl fumarate, and 735 receiving teriflunomide. Individuals treated with fingolimod, dimethyl fumarate, or teriflunomide switched treatment significantly more quickly than matched cladribine tablet cohorts (adjusted hazard ratio (95% confidence interval): 4.00 (2.54-6.32), 7.04 (4.16-11.93), and 6.52 (3.79-11.22), respectively). Cladribine tablet cohorts had significantly longer time-to-treatment discontinuation, time to first relapse, and lower ARR, compared with other oral DMT cohorts.CONCLUSION: Cladribine tablets were associated with a significantly greater real-world treatment persistence and more favorable relapse outcomes than all oral DMT comparators.
AB - BACKGROUND: Effectiveness of cladribine tablets, an oral disease-modifying treatment (DMT) for multiple sclerosis (MS), was established in clinical trials and confirmed with real-world experience.OBJECTIVES: Use real-world data to compare treatment patterns and clinical outcomes in people with MS (pwMS) treated with cladribine tablets versus other oral DMTs.METHODS: Retrospective treatment comparisons were based on data from the international MSBase registry. Eligible pwMS started treatment with cladribine, fingolimod, dimethyl fumarate, or teriflunomide tablets from 2018 to mid-2021 and were censored at treatment discontinuation/switch, death, loss to follow-up, pregnancy, or study period end. Treatment persistence was evaluated as time to discontinuation/switch; relapse outcomes included time to first relapse and annualized relapse rate (ARR).RESULTS: Cohorts included 633 pwMS receiving cladribine tablets, 1195 receiving fingolimod, 912 receiving dimethyl fumarate, and 735 receiving teriflunomide. Individuals treated with fingolimod, dimethyl fumarate, or teriflunomide switched treatment significantly more quickly than matched cladribine tablet cohorts (adjusted hazard ratio (95% confidence interval): 4.00 (2.54-6.32), 7.04 (4.16-11.93), and 6.52 (3.79-11.22), respectively). Cladribine tablet cohorts had significantly longer time-to-treatment discontinuation, time to first relapse, and lower ARR, compared with other oral DMT cohorts.CONCLUSION: Cladribine tablets were associated with a significantly greater real-world treatment persistence and more favorable relapse outcomes than all oral DMT comparators.
KW - disability
KW - discontinuation
KW - MS
KW - real-world data
KW - registry
KW - relapse
KW - switching
UR - http://www.scopus.com/inward/record.url?scp=85142793324&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85142793324&partnerID=8YFLogxK
UR - http://www.ncbi.nlm.nih.gov/pubmed/36433775
UR - https://www.mendeley.com/catalogue/3f081f97-416b-308a-bea0-ab6b9f66f5bc/
U2 - 10.1177/13524585221137502
DO - 10.1177/13524585221137502
M3 - Article
C2 - 36433775
SN - 1352-4585
VL - 29
SP - 13524585221137502
JO - Multiple Sclerosis Journal
JF - Multiple Sclerosis Journal
IS - 2
ER -